Job Information
RETROPHIN, INC. Sr. Laboratory Auditor, Quality Assurance GLP in SALT LAKE CITY, Utah
Department:
107100 Quality
Location:
San Diego, USA- Remote
Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
Position Summary:
The Sr. Laboratory Auditor, Quality Assurance GLP is responsible for actively supporting the implementation of GLP (e.g., Bioanalytical/Biomarker) initiatives and for leading the execution of quality related activities. In addition to the performance of laboratory audits, this position will assist with management of the audit program and partner with key clinical and cross-functional groups (e.g., Clinical Operations, Biometrics, Bioanalytical/Non-Clinical Development) to ensure the integrity of data generated for preclinical and clinical development programs and ensuring our contracted laboratories meet stringent pharma industry standards.
Essential Functions:
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Develop and implement risk-based audit strategies across clinical programs and/or studies with an emphasis on Bioanalytical studies to support Clinical and non-Clinical Bioanalytical Laboratory oversight.
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Plan, conduct and manage audits of pharmaceutical laboratories supporting nonclinical, clinical, and bioanalytical studies to ensure adherence to GLP/GCLP and relevant ICH guidelines.
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Evaluate laboratory systems including method validation, sample management, data integrity (ALCOA+ principles), equipment calibration/maintenance, and SOP compliance.
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Prepare comprehensive audit plans and reports, documenting findings, and recommendations for remediation. For those audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.
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Provide input and expertise to vendor risk assessments and qualification activities in support of GLP/GCLP Vendor/Service Provider Qualification Program.
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Identify, communicate, and escalate GLP/GCLP risks and serious non-compliance situations and follow to resolution, acting with an appropriate sense of urgency.
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Partner with internal stakeholders to manage vendor oversight and/or issue management.
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Conduct and/or facilitate investigations of GLP/GCLP Quality Events and collaborate with subject matter experts to conduct root cause analysis and to develop corrective and preventive action plans, as applicable.
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Manage and/or actively support the development, enhancement, review, and implementation of GLP quality standards and controlled documents (e.g., Policies, SOPs, Work Instructions, Templates)
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Promote compliance and quality throughout the company and represent the Quality Department in internal meetings and events.
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Build, develop and maintain working relationships with inter nal and external partners.
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Participate in the... For full info follow application link.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer